Healthy Skepticism Library item: 13012

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Publication type: news

Hirschler B.
Drug test laws to be tightened after Glaxo probe
Reuters 2008 Mar 6
http://uk.reuters.com/article/hotStocksNews/idUKL0680920020080306?rpc=401&feedType=RSS&feedName=hotStocksNews&rpc=401

Full text:

LONDON (Reuters) – The government is to strengthen the law on disclosing drug trial results following a four-year inquiry into GlaxoSmithKline’s delay in reporting data linking its antidepressant Seroxat to suicide risk in teenagers.

“We will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies’ obligations to report safety issues,” Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said in a statement on Thursday.

The watchdog advised doctors in 2003 not to give Seroxat to patients under the age of 18, after Glaxo handed over data showing it could increase their risk of suicidal behaviour.

An investigation with a view to potential criminal prosecution was launched due to concerns that Europe’s biggest drugmaker had held the information for some time before this and failed to disclose it.

In the event, government prosecutors had concluded there was no realistic prospect of a conviction in the case and it should not proceed to criminal prosecution.

Glaxo officials were not immediately available to comment.

Seroxat, which belongs to a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, is sold as Paxil in the United States,

(Reporting by Ben Hirschler; Editing by David Cowell)